Hologic Lead Engineer - Consumables in Marlborough, Massachusetts

Lead Engineer - Consumables

Post Date Jun 25, 2018

Summary of Duties and Responsibilities

You will be part of an enthusiastic, dynamic, results-oriented team of development engineers, and interface directly with scientists, product managers, regulatory specialists, quality engineers and manufacturing operations working to define and develop Hologic’s best-in-class biopsy products. The ideal candidate is one who understands biopsy medical devices and how they are used in the clinical environment.

  • Create and manage product requirements and designspecifications.

  • Directs activities to ensure that manufacturing,construction and operational testing conform to functional specifications,user needs, and customer requirements.

  • Uses computer assisted engineering and design softwareto perform engineering tasks.

  • Lead technical development team, as required.

  • Produce DHF documentation in support of designprojects.

  • Complete design documentation and Engineering ChangeOrders, as required by Hologic standard operating procedures.

  • Hold device design requirements reviews with internaland external stakeholders (suppliers) as required

  • Develop and maintain component or high level assemblypurchasing specifications, including critical to quality parameters,ensuring requirements are well defined, and suppliers can fulfill and testto the specifications

  • Propose alternative design concepts in collaborationwith other technical staff, to meet product definitions and evaluate basedon risk, product cost, performance, safety, and reliability considerations

  • Ensure that design implementation and test methods aredeveloped and executed in a manner that supports quality standards,whether designed in-house, or utilizing suppliers

  • Performs a wide variety of complex technical tasks toassist design engineers with developmental operations.

  • Create and/or participate in developing DesignRequirement Documents, Design Verifications, Work Procedures and TestProcedures.

  • Facilitate Design Transfer to Manufacturing.

  • Work in FDA/ISO/MDD regulated environment.

  • Recognizes and reports problems affecting successfulcompletion of project, is instrumental in suggesting or effectingsolution.

  • Significant technical contributor to generation ofspecifications and schedules.

  • Manages outside resources, as required.

Qualifications

  • Demonstrated understanding of:

  • full product development cycle of medical devices fromconcept to product delivery

  • use of biopsy devices in the clinical environment

  • the design, fabrication and assembly of medicaldevices incorporating plastic and metal parts

  • Ability to:

  • work well with diverse groups of people, interacteffectively with cross-functional teams and partner with functionalmanagers and other departments

  • manage multiple tasks and priorities simultaneouslyand adapt to changes in program priorities

  • transform physical and mathematical concepts intosound engineering designs

  • define clear and effective product design requirementsand specifications

  • communicate effectively, both in writing and verbally

  • Strong background in 3D modeling, Solidworks preferred.

  • Familiar with international standards forbiocompatibility of materials used in medical devices

  • Familiar with FDA QSR and ISO 13485 design controlrequirements.

  • Proficiency with Microsoft Office.

Education

  • Bachelor’s degree in Biomedical or Mechanical Engineering

  • Master’s degree in Engineering, a plus

Experience

  • Aminimum 10 years of experience designing and developing medical devices.

Additional Details

(Including Physical & Mental requirements)

  • Must be able to repetitively lift and carryproduct weighing approximately 30 lbs.

  • Up to 20% travel as necessary with potential forinternational travel

Agency and Third PartyRecruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employerinclusive of disability and veterans.